Effect of Transcatheter Aortic Valve Implantation vs Surgical Aortic Valve Replacement on All-Cause Mortality in Patients With Aortic Stenosis
Authors: Timothy Fairbairn, Ian Kemp, Andrea Young, Christina Ronayne, Janet Barton, Joanne Crowe, Lorraine McQuade, Nichola Clarkson, Michail Sionas, Angela Tobin, Sarah Feeney, Deborah Dickerson, Jacqueline Currie, Robert Shaw, Catherine Sudarshan, Yasir Abu-Omar, Michael O'Sullivan, William Davies, Rebecca McClean, Lisa Wong, Goher Ayman, Bushra Rana, Lynne Williams, Rosemary Rusk, Raj Kharbanda, George Krasopoulos, Jim Newton, Stephanie Lloyd, Deborah Barker, Heather Naylor, Stuart Grant, Anu Oommen, Thabitha Charles, Sarah Mackie, Martin Sherwood, Elaine Pickett, James Cockburn, Adam de Belder, Amit Modi, Jessica Parker, Nicola Skipper, Sara Appasamy, Cath Thomson, Ari Gomes, Neil E Moat, Cesare Quarto, Rashmi Yadav, ShuFang Wang, Teijo Palovaara, Suad Warsama, John Rawlins, Alison Calver, Geoff Tsang, Miskolczi Szabolcs, Karen Banks, Zoe Nicholas, Sam Gough, Julie Bigg, Judith Radmore, Dhrubo Rakhit, Benoy Shah, Di Gardner, Daniel Blackman, Michael Cunnington, Betsy Evans, Francesco Pirone, Kalyana Javangula, Kathryn Somers, Helen Reed, Natalie Gregory, Dominik Schlosshan, Katrina Bounford, Paul Williams, Andrew Goodwin, Sharareh Vahabi, Matthew Jackson, Bilal Bawamia, Stephanie Mack, Karen McLeod, Heather Robinson, Bev Atkinson, Nicola Cunningham, Jeetendra Thambyrajah, Sam Middleton, Nick Cruden, Andrew Flapan, Vipin Zamvar, Belinda Rif, James Harrison, Sharon Lockie, Mohammed Akhtar, Steve Hamshere, Neil Roberts, Mervyn Andiapen, Rita Adrego, Delfin Encarnacion, Jonathan Byrne, Ranjit Deshpande, Max Baghai, Michelle Andrews, Abigail Knighton, James Cotton, Heyman Luckraz, Andy Smallwood, Stella Metherell, Raj Das, Azfar Zaman, Kathryn Proctor, Ursula Harrison, Tito Kabir, Vas Panoulas, Claire Prendergast, Paula Rogers, Shelley Rahman Haley, Alagumeenakshi Navaneethakrishnan, Tomasz Spyt, Mark Hickey, Elved Roberts, Donna Alexander, Elaine Logtens, Derek Chin, Jeffrey Khoo, Anna-Marie Marsh, John McAdam, Marion Campton, Malcolm Dalrymple-Hay, Venkat Suresh, Natasha Wilmshurst, Linda Zacharkiw, Christopher Allen, Megan Bell, Karen Wilson, Mushfeq Alam, Ian Massey, Jill Wain, Rebecca Griffiths, Will Winder, Robert Henderson, Surendra Naik, Adam Szafranek, Kamran Baig, Richard Varcoe, Rachel King, Victoria Kozlowski, Sonia Rubie, Andreas Baumbach, Stephen H Dorman, Cha Rajakaruna, Laura Gallego, Sheila Bell, Ruth Bowles, Laura Wilkinson, Jo Roberts, Mandie Townsend, David Smith, Aprim Youhana, Alexander Chase, Pankaj Kumar, Gladdys Thomas, Claire Fagan, Jane Griffiths, Alisa Wallis, Bohdana Bahlay, David Roberts, Augustine Tang, Amal Bose, Vasanthi Vasudevan, Peter H Groves, Indu Deglurkar, Richard Anderson, Vaseem Farooq, Ayush Khurana, Nick Ossei-Gerning, Dheeraj Mehta, Richard Wheeler, Helen Dyer, Julie Edwards, Elizabeth Hodges, Elizabeth Thompson, Patricia Thomas, Lesley Davies, Gillian Andrew, Stephen Hiles, Jacqueline Holder, Sam Bowen, Lona Hanzel, Margaret B McEntegart, Nawwar Al-Attar, Keith G Oldroyd, Elaine Matthews, Sagar N Doshi, Jorge Mascaro, Jonathan N Townend, Aaron Ranasinghe, Adnan Nadir, Annette Nilsson, Richard Steeds, Richard Levy, Mamta Buch, Isaac Kadir, Jaydeep Sarma, Saqib Chowdhary, Paul Waterworth, Akhila Muthuswamy, Lindsey McDowell, Cathy Barman, Jane Lynch, Anita MacNab, Laura Dobson, Stephen Brecker, Venkatachalam Chandrasekaran, Vennessa Sookhoo, Raj Sharma, Sue Brown, Ghada Mikhail, Andrew Chukwuemeka, Iqbal Malik, Jon Anderson, Angela Frame, Petros Nihoyannopoulos, Thirumaran Rajathurai, Thomas Barker, Luke Tapp, Catherine Gibson, Samantha Hyndman, Luke Mahoney, Laura Speke, Lynn Gardener, Ever Grech, Norman Briffa, Ian Hall, Govind Chetty, Stefano Forlani, Mel Neville, Kay Hounsley, Laurence O'Toole, Mark S Spence, Reuben Jeganathan, Colum G Owens, Bernie Smith, Nicola Johnston, Inderpaul Birdi, Rajesh Aggarwal, Madelaine Ocampo, Annaliza Sevillano, Johannes Pintacasi, Mahmoud Loubani, Raj Chelliah, Mubarak Chaudhry, Karen Dobbs, Doug Altman, Tim Daniel, Graham Fancourt, Marjan Jahangiri, Martin Bland, Dawn Saunders, Nicholas Boon, Ian Wilkinson, Stuart M Cobbe, Wil Woan, Graham Cooper, John McMurray, Lars Kober, Peter Crean, Tom Treasure, Ian Ford, Marc Randall, Sanjeev Bhattacharyya, John Dean, Abtehale Al-Hussaini, James Yeh, Priyanka Batra, Vicki Barber, Samuel Fatoba, Surjeet Singh, Elena Villarreal, Mark Butler, Alexis Webb, Jim Palmer, Lazarina Engonidou, Aimi Hewitt, Virginia Chiocchia, Beverly Shirkey, Susan Dutton, Lei Clifton, Mark Forrest, Gladys McPherson, Brian Taylor, Keith Pearce, Martin Stout, Andrew Whittaker, Katherine Kuyt, Tiago Fonseca, William D. Toff, David Hildick-Smith, Jan Kovac, Michael J. Mullen, Olaf Wendler, Anita Mansouri, Ines Rombach, Keith R. Abrams, Simon P. Conroy, Marcus D. Flather, Alastair M. Gray, Philip MacCarthy, Mark J. Monaghan, Bernard Prendergast, Simon Ray, Christopher P. Young, David C. Crossman, John G. F. Cleland, Mark A. de Belder, Peter F. Ludman, Stephen Jones, Cameron G. Densem, Steven Tsui, Manoj Kuduvalli, Joseph D. Mills, Adrian P. Banning, Rana Sayeed, Ragheb Hasan, Douglas G. W. Fraser, Uday Trivedi, Simon W. Davies, Alison Duncan, Nick Curzen, Sunil K. Ohri, Christopher J. Malkin, Pankaj Kaul, Douglas F. Muir, W. Andrew Owens, Neal G. Uren, Renzo Pessotto, Simon Kennon, Wael I. Awad, Saib S. Khogali, Maciej Matuszewski, Richard J. Edwards, Bandigowdanapalya C. Ramesh, Miles Dalby, Shahzad G. Raja, Giovanni Mariscalco, Clinton Lloyd, Ian D. Cox, Simon R. Redwood, Mark G. Gunning, Paul D. Ridley
Journal: JAMA (2022)

Transcatheter aortic valve implantation (TAVI) is a less invasive alternative to surgical aortic valve replacement and is the treatment of choice for patients at high operative risk. The role of TAVI in patients at lower risk is unclear.To determine whether TAVI is noninferior to surgery in patients at moderately increased operative risk.In this randomized clinical trial conducted at 34 UK centers, 913 patients aged 70 years or older with severe, symptomatic aortic stenosis and moderately increased operative risk due to age or comorbidity were enrolled between April 2014 and April 2018 and followed up through April 2019.TAVI using any valve with a CE mark (indicating conformity of the valve with all legal and safety requirements for sale throughout the European Economic Area) and any access route (n = 458) or surgical aortic valve replacement (surgery; n = 455).The primary outcome was all-cause mortality at 1 year. The primary hypothesis was that TAVI was noninferior to surgery, with a noninferiority margin of 5% for the upper limit of the 1-sided 97.5% CI for the absolute between-group difference in mortality. There were 36 secondary outcomes (30 reported herein), including duration of hospital stay, major bleeding events, vascular complications, conduction disturbance requiring pacemaker implantation, and aortic regurgitation.Among 913 patients randomized (median age, 81 years [IQR, 78 to 84 years]; 424 [46%] were female; median Society of Thoracic Surgeons mortality risk score, 2.6% [IQR, 2.0% to 3.4%]), 912 (99.9%) completed follow-up and were included in the noninferiority analysis. At 1 year, there were 21 deaths (4.6%) in the TAVI group and 30 deaths (6.6%) in the surgery group, with an adjusted absolute risk difference of -2.0% (1-sided 97.5% CI, -∞ to 1.2%; P < .001 for noninferiority). Of 30 prespecified secondary outcomes reported herein, 24 showed no significant difference at 1 year. TAVI was associated with significantly shorter postprocedural hospitalization (median of 3 days [IQR, 2 to 5 days] vs 8 days [IQR, 6 to 13 days] in the surgery group). At 1 year, there were significantly fewer major bleeding events after TAVI compared with surgery (7.2% vs 20.2%, respectively; adjusted hazard ratio [HR], 0.33 [95% CI, 0.24 to 0.45]) but significantly more vascular complications (10.3% vs 2.4%; adjusted HR, 4.42 [95% CI, 2.54 to 7.71]), conduction disturbances requiring pacemaker implantation (14.2% vs 7.3%; adjusted HR, 2.05 [95% CI, 1.43 to 2.94]), and mild (38.3% vs 11.7%) or moderate (2.3% vs 0.6%) aortic regurgitation (adjusted odds ratio for mild, moderate, or severe [no instance of severe reported] aortic regurgitation combined vs none, 4.89 [95% CI, 3.08 to 7.75]).Among patients aged 70 years or older with severe, symptomatic aortic stenosis and moderately increased operative risk, TAVI was noninferior to surgery with respect to all-cause mortality at 1 year.isrctn.com Identifier: ISRCTN57819173.